U.S. patent number 6,447,799 [Application Number 09/670,451] was granted by the patent office on 2002-09-10 for thromboplastic system.
Invention is credited to Joseph M. Ullman.
United States Patent |
6,447,799 |
Ullman |
September 10, 2002 |
Thromboplastic system
Abstract
A thromboplastic system and related method for establishing
hemostasis. The kit includes an absorptive pad, a thrombin
retainer, and a non-stick backing. The absorptive pad may be a foam
pad or a set of foam pads. The retainer may be a single bubble pack
having the thrombin therein, or a set of bubble packs, one with
thrombin and the other with a diluent. The retainer includes a
breakable base, such as a foil base, that keeps the thrombin
separate from the pad until forced open. When that happens, the
thrombin moves into the pad to form a thrombin-soaked gelatin foam
pad. The pad may then be applied to a wound. An applicator may be
used to maintain uniform pressure on the pad over the wound.
Inventors: |
Ullman; Joseph M. (Falmouth,
ME) |
Family
ID: |
26914851 |
Appl.
No.: |
09/670,451 |
Filed: |
September 26, 2000 |
Current U.S.
Class: |
424/447;
128/DIG.22; 604/290; 604/306 |
Current CPC
Class: |
A61L
15/32 (20130101); A61M 31/002 (20130101); Y10S
128/22 (20130101) |
Current International
Class: |
A61L
15/16 (20060101); A61L 15/32 (20060101); A61M
31/00 (20060101); A61L 015/32 (); A61M
035/00 () |
Field of
Search: |
;128/DIG.22
;604/890.1,1,2,3,290,304,306,307,308
;424/443,444,445,446,447,448,449 |
References Cited
[Referenced By]
U.S. Patent Documents
Primary Examiner: Russel; Jeffrey E.
Attorney, Agent or Firm: Atwood; Pierce
Parent Case Text
CROSS-REFERENCE TO RELATED APPLICATION
This application claims the priority benefit of provisional
application Ser. No. 60/220,405 filed Jul. 24, 2000, of the same
title and by the same inventor.
Claims
What is claimed is:
1. A thromboplastic kit comprising: a. an absorptive pad having a
first side and a second side; b. a thrombin retainer attached to
said first side of said absorptive pad, wherein said thrombin
retainer retains thrombin therein; and c. a non-stick backing
attached to said second side of said pad.
2. The thromboplastic kit as claimed in claim 1 wherein said
thrombin retainer is a plastic bubble pack.
3. The thromboplastic kit as claimed in claim 2 wherein said
thrombin retainer further includes a breakable backing coupling
said bubble pack to said first side of said absorptive pad.
4. The thromboplastic kit as claimed in claim 1 further comprising
a sealing pack for retaining said pad, said thrombin retainer and
said non-stick backing therein.
5. A thromboplastic kit comprising: a. an absorptive pad having a
first side and a second side; b. a first thrombin component
retainer attached to said first side of said absorptive pad,
wherein said first thrombin component retainer retains thrombin
therein; c. a second thrombin component retainer attached to said
first side of said absorptive pad, wherein said second thrombin
component retainer retains a thrombin diluent therein; and d. a
non-stick backing attached to said second side of said pad.
6. The thromboplastic kit as claimed in claim 5 wherein said first
thrombin component retainer and said second thrombin component
retainer are plastic bubble packs.
7. The thromboplastic kit as claimed in claim 6 wherein said first
thrombin component retainer and said second thrombin component
retainer include a common breakable backing coupling both of said
bubble packs to said first side of said absorptive pad.
8. The thromboplastic kit as claimed in claim 5 further comprising
a sealing pack for retaining said pad, said first thrombin
component retainer, said second thrombin component retainer, and
said non-stick backing therein.
9. The thromboplastic kit as claimed in claim 5 wherein said
thrombin is lyophilized thrombin.
10. A method for establishing hemostasis using a thromboplastic
kit, the kit comprising an absorptive pad with a thrombin retainer
means isolating thrombin from the absorptive pad, the method
comprising the steps of: a. applying pressure to the thrombin
retainer means to force thrombin to exit the thrombin retainer
means and enter the absorptive pad; b. massaging the absorptive pad
so that the thrombin and pad combine to form a thrombin-soaked pad;
and c. applying said thrombin-soaked pad to a wound.
11. The method as claimed in claim 10 wherein the thrombin retainer
means includes a retainer pack having thrombin therein.
12. The method as claimed in claim 10 wherein the thrombin retainer
means includes a first thrombin component retainer pack having
thrombin therein, and a second thrombin component retainer pack
having a thrombin diluent therein.
13. The method as claimed in claim 12 wherein the thrombin is
lyophilized thrombin.
14. The method as claimed in claim 10 further comprising the step
of forcing said pad onto the wound with a pressure applicator.
Description
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates to systems for accelerating the
clotting of blood. More particularly, the present invention relates
to a foam pack kit for applying thrombin or a similar clotting
agent to a wound.
2. Description of the Prior Art
Every week, 360,000 Americans undergo hemodialysis three (3) times
a week. Most, if not all, of those patients have a tube under the
skin to establish a fluid transfer path. In order to complete the
flow path through the dialysis machine, two openings or wounds must
be made in the patient in order to connect the tube to the machine.
Specifically, the tube, sometimes referred to as a graft, connects
an artery and vein. The connection, when pressurized, creates an
artificial high-flow conduit that can be repeatedly punctured with
large bore needles to allow dialysis. In many other cases, a
surgical connection is established between the artery and vein. The
surgical connection is known as a fistula. It accomplishes
substantially the same function as the graft. Therefore, on the
three-per-week dialysis schedule, each patient must be accessed
through graft or fistula openings six times per week.
The graft and fistula structures function nearly at systemic blood
pressure. Therefore, when they are removed, considerable bleeding
occurs. Traditionally, fingertip pressure is applied by healthcare
personnel, in some cases for a minimum of 10 minutes, and often
longer, in order to stem the bleeding. Under repeated dialysis
procedures, the fistula and grafts may not easily be re-opened in
that they often become clotted or narrowed. It therefore becomes
necessary to use larger bore needles and tubes to establish an
appropriate fluid pathway. The larger wounds associated with these
larger openings often translate into longer time periods to halt
bleeding when the devices are removed.
Isolated efforts have been made to improve the hemostasis process.
In one instance, the present inventor developed and employed in
limited circumstances in some healthcare facilities, a system for
that purpose. Initially, the effort involved simply applying a
gelatin foam sponge to the wound site, with pressure, to accelerate
hemostasis, or clotting, at the puncture site. This reduced the
time to clotting, but the time required was still considerable.
Recently, thrombin, a protein agent that accelerates clotting, was
added to the sponge. The particular system involves cutting the
sponge and applying to that sponge a mixture of the two components
used to create the commercially available thrombin. The combination
results in a gel-like solid structure that may be applied directly
to the wound. The combination accelerates the clotting very well.
In addition, a small square of a non-stick gauze pad, such as a
Telfa.TM. pad, may be placed on the surface of the foam/thrombin
combination to prevent unintended sticking of the foam prior to
application to the wound.
Unfortunately, while the combination described above works well as
a thromboplastic system, it is a jury-rig arrangement requiring as
much or more time to make as it does to clot the blood using hand
pressure. Moreover, there may be inconsistency in the amount of
thrombin applied to the foam, the adequacy of the size of the foam
pad, and the opportunity to forget the application of the non-stick
pad. Therefore, what is needed is a ready-to-use system for
conveniently and adequately establishing hemostasis, whether after
a dialysis procedure or in regard to clotting any wound. Also,
given the scope of the problem--many thousands of wounds daily
throughout the world requiring clotting--such a system must be
relatively inexpensive to obtain and relatively easy to use.
SUMMARY OF THE INVENTION
In view of the foregoing, it is an object of the present invention
to provide a ready-to-use system for conveniently and adequately
establishing hemostasis in a wound. It is also an object of the
invention to provide such a thromboplastic system that is
relatively inexpensive to obtain and relatively easy to use.
These and other objects are achieved with the present invention,
which is a three-part kit for establishing hemostasis. The kit
includes a pre-packaged combination of the sponge foam, pre-cut
into an array of selectable sizes, to which the non-stick gauze is
attached. A thrombin-containing device, such as a small blister or
tear-through bubble pack, is included in the kit. It may be affixed
to the side of the foam that is not coupled to the gauze.
Alternatively, two small blisters or packets may be affixed to that
side of the foam; one packet containing lyophilized (freeze-dried)
thrombin and the other a thrombin diluent.
In the process associated with use of the present system to protect
a wound, either the single thrombin-containing device is opened, or
the two bubbles are pinched or pressed together and mixed. The
thrombin or the thrombin/diluent mixture then enters the foam
directly to create a gel/foam combination that may be applied
directly to the wound. Pressure is then applied to the gauze side
that does not stick to the pressure-applying structure. That
structure may be a sterile stick or a healthcare provider's covered
fingers.
The present invention eliminates the need to have three different
products, the need to cut individual foam and gauze pieces, and the
need to obtain and manipulate a thrombin bottle. It also eliminates
the need to stick a syringe under sterile conditions into the
bottle, pull it out, squirt the thrombin onto the foam, make a
sandwich with the gauze and only after all that stick the
combination on the wound. The present invention reduces supplies,
waste, and accidental needle sticks. Given the cost of the
individual components, the kit would be relatively inexpensive in
comparison to the excess materials and healthcare provider's time
involved in making each part.
In summary, the present invention is a self-contained small packet
or kit with one or more pieces of an absorptive foam, one side of
which is backed with a non-stick material, such as gauze, to reduce
adherence on the opposing side, and one or more breakably sealed
blisters on the other side. The blister or blisters are manipulated
to activate the thrombin reagent and deliver it to the foam. The
impregnated foam may then be applied to the wound site.
These and other advantages of the present invention will be
understood upon review of the drawings, the detailed description,
and the appended claims.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is a side view of a simplified representation of a first
embodiment of the thromboplastic system of the present invention,
showing a single thrombin-retaining element.
FIG. 2 is a top view of a simplified representation of the first
embodiment of the thromboplastic system of FIG. 1.
FIG. 3 is a side view of a simplified representation of a second
embodiment of the thromboplastic system of the present invention,
showing a thrombin-mixing packet element.
FIG. 4 is a top view of a simplified representation of the second
embodiment of the thromboplastic system of FIG. 3.
FIG. 5 is a side view of a simplified representation of the second
embodiment of the thromboplastic system with the thrombin-mixing
packet opened to deliver its contents into the thrombin-delivering
foam gauze.
FIG. 6 is a side view of a simplified representation of the second
embodiment of the thromboplastic system with the thrombin gel/foam
gauze combination applied to a wound.
DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS
A first thromboplastic system or kit 10 of the present invention is
illustrated in FIGS. 1 and 2. The system 10 includes a thrombin
receiving pad 11, a thrombin retainer 12, a pad backing 13, and a
sealing pack 14 to hold the other parts therein in a sterile
environment until ready for use. The pad 11 may be a gelatin foam
pad, or a set of such pads, suitable for absorbing thrombin within
the retainer 12 when the retainer 12 is broken open to release the
thrombin onto and into the pad 11. The retainer 12 is preferably a
plastic bubble pack including a foil or other suitable breakable
sealing base 15 that is affixed to the pad 11. The sealing base 15
keeps the thrombin away from the pad 11 until the two are to be
combined for use to seal a wound. When that occurs, a foam/gel pad
is created for that purpose. The backing 13 includes first surface
for attachment to the pad 11 and an opposing non-adherent or
non-stick surface to contact a patient's skin. The backing 13 is
affixed to the pad 11 on its surface opposite that of the retainer
12. The sealing pack 14 is of any type suitable for holding the
contents therein in a sterile environment. One such type may be a
retainer pack used to enclose sterile gauze pads or other retainers
well known by those skilled in the healthcare field.
A second embodiment of the present invention is shown in FIGS. 3
and 4. A second thromboplastic system or kit 20 of the present
invention includes a thrombin receiving gelatin foam pad 21, a
first thrombin component retainer 22, a second thrombin component
retainer 23, a pad backing 24, and a sealing pack 25 to hold the
other parts therein in a sterile environment until ready for use.
As with the pad 11 of the first system 10, the pad 21 may be a
sterile gelatin foam pad, or a set of such pads, suitable for
absorbing thrombin when retainers 22 and 23 are broken open and
combined to release onto and into the pad 21. The first and second
retainers 22 and 23 are each plastic bubble packs that may include
a common foil or other suitable breakable sealing base 26 that is
affixed to the pad 21. It is to be understood that each of the
retainers 22 and 23 is designed to isolate their respective
contents from one another until those contents are intentionally to
be combined together. The sealing base 26 keeps the thrombin
components away from the pad 21 until the two are to be combined
for use to seal a wound. When that occurs, a thrombin enriched
gelatin pad is created. The backing 24 includes a first surface for
attachment to the pad 21 and an opposing non-adherent or non-stick
surface to contact a patient's skin. The backing 24 is affixed to
the pad 21 on its surface opposite that of the retainers 22, 23.
The sealing pack 25 is of any type suitable for holding the
contents therein in a sterile environment. One such type may be a
retainer pack used to enclose sterile gauze pads or other retainers
well known by those skilled in the healthcare field.
The method of the present invention for wound sealing using the
foam/thrombin gel is fairly straightforward and involves steps
associated with the stages of modification of system 20 represented
in FIGS. 5 and 6. First, the healthcare provider presses downward
on the two retainers 22 and 23 such that their contents force the
sealing base 26 to open, such as at opening regions 27 and 28. The
contents of the retainers 22 and 23, which may be lyophilized
thrombin and a thrombin diluent, respectively, are then released
into the pad 21. Massaging or other manipulation of the pad 21
forces a mixing of the two components together within the pad 21
and produces a thrombin enriched gel foam pad 29. The gel pad 29 is
removed from the pack 25 and then applied on a patient's skin 30
over a wound 31, as shown in FIG. 6. The healthcare provider may
leave the pad 29 in place, or may apply pressure to the wound 31
either by hand or with a uniform pressure applicator 32 having a
handle 33 and a wide pressure plate 34. Although the method
described has been presented with respect to use of the second
system 20, it is to be understood that the same process is
applicable with the single retainer 12 of the first system 10.
While the invention has been described with reference to a
particular example embodiment, it is intended to cover all
modifications and equivalents as described in the following
claims.
* * * * *